Study of New Antibiotic Regimen for the Treatment of Uncomplicated Cellulitis in Emergency Department Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00676130
Recruitment Status : Completed
First Posted : May 12, 2008
Results First Posted : August 14, 2012
Last Update Posted : August 14, 2012
Information provided by (Responsible Party):
Daniel Jay Pallin, MD, MPH, Brigham and Women's Hospital

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Cellulitis
Interventions: Drug: trimethoprim-sulfamethoxazole
Drug: Cephalexin

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
We enrolled generally-healthy subjects with uncomplicated acute cellulitis from 6/2007 to 12/2011. Eligible subjects were adults and children presenting to EDs of 3 teaching hospitals in Boston, MA.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Each subject was assigned randomly to a treatment group by the institutions’ research pharmacies. The research pharmacies had no knowledge of subjects’ clinical characteristics. Treating (non-research) clinicians, research clinicians, coordinators, and subjects had no knowledge of the randomization sequence.

Reporting Groups
Trimethoprim-sulfamethoxazole Cephalexin plus trimethoprim-sulfamethoxazole
Placebo Cephalexin plus placebo

Participant Flow:   Overall Study
    Trimethoprim-sulfamethoxazole   Placebo
STARTED   76   77 
COMPLETED   73   73 
Lost to Follow-up                0                1 
Found ineligible                3                2 
Withdrawal by Subject                0                1 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
Trimethoprim-sulfamethoxazole Cephalexin plus trimethoprim-sulfamethoxazole
Placebo Cephalexin plus placebo
Total Total of all reporting groups

Baseline Measures
   Trimethoprim-sulfamethoxazole   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 76   77   153 
[Units: Participants]
<=18 years   3   5   8 
Between 18 and 65 years   68   69   137 
>=65 years   5   3   8 
[Units: Years]
Mean (Standard Deviation)
 37.03  (15.07)   32.43  (15.15)   34.71  (15.23) 
[Units: Participants]
Female   39   36   75 
Male   37   41   78 
Region of Enrollment 
[Units: Participants]
United States   76   77   153 

  Outcome Measures

1.  Primary:   Relative Efficacy   [ Time Frame: 12 +/- 2 days; 30 +/- 2 days ]

2.  Secondary:   Progression to Abscess   [ Time Frame: 12 +/- 2 days, 30 days +/- 2 days ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  
Name/Title: Daniel J. Pallin, MD, MPH
Organization: Brigham and Women's Hospital
phone: 617-525-6614

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Daniel Jay Pallin, MD, MPH, Brigham and Women's Hospital Identifier: NCT00676130     History of Changes
Other Study ID Numbers: 2007P000414
First Submitted: December 28, 2007
First Posted: May 12, 2008
Results First Submitted: July 3, 2012
Results First Posted: August 14, 2012
Last Update Posted: August 14, 2012